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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 2341–2360 of 17,723 recalls

Class IITerminated

heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · Drug

View details →

Class IITerminated

tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IITerminated

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →

Class IIITerminated

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →

Class IIITerminated

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →

Class IIITerminated

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →

Class IIITerminated

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →

Class IIITerminated

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →

Class IIOngoing

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

April 26, 2023 · DrugView details →

Class IIOngoing

Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

April 26, 2023 · DrugView details →

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